AzTrials
AzTrials

Rib FractureNCT07553208

SPSIP vs ESP Block for Analgesia After Rib Fracture Surgery

A study testing Erector Spinae Plane Block (ESP) and Serratus Posterior Superior Intercostal Plane (SPSIP) in people with Rib Fracture and Postoperative Pain, run by Antalya City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) block and the Erector Spinae Plane (ESP) block in patients undergoing surgical stabilization of rib fractures. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rib Fracture, Postoperative Pain, Thoracic Trauma
What is being tested?
Erector Spinae Plane Block (ESP) and Serratus Posterior Superior Intercostal Plane (SPSIP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2026to 15 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective video-assisted thoracoscopic surgery
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Ability to understand and use the patient-controlled analgesia (PCA) device
  • Ability to provide written informed consent

Who cannot join

  • Refusal to participate
  • Allergy to local anesthetics
  • Infection at the injection site
  • Coagulopathy or ongoing anticoagulant therapy
  • Chronic opioid use or opioid dependence
  • Severe hepatic or renal insufficiency
Show all 9Show fewer
  • Pregnancy or breastfeeding
  • Cognitive impairment or inability to communicate pain scores
  • Body mass index (BMI) <18 or >35 kg/m²

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mustafa KILIN, Consultant Anesthesiologist contact

+905464569218

mustafa.kilin90@gmail.com

Turkey (Türkiye)1 site
  • Antalya City Hospitial, Ministry of Health, Turkey

    Antalya

    MUSTAFA KILIN, Consultant Anesthesiologist, +905464569218, mustafa.kilin90@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Surgical Stabilization of Rib Fractures: a Prospective Randomized Controlled Trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) block and the Erector Spinae Plane (ESP) block in patients undergoing surgical stabilization of rib fractures. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and quality of recovery assessed using the QoR-15 questionnaire.

Read the detailed description

This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Serratus Posterior Superior Intercostal Plane (SPSIP) and Erector Spinae Plane (ESP) block on Visual Analog Scale (VAS) scores in patients undergoing surgical stabilization of rib fractures. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours and postoperative recovery quality.

Materials and Methods:

This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) <35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.

Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer- generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.

Study Groups and Block Procedures: Group SPSIP will receive a unilateral SPSIP block, and Group ESP will receive a unilateral ESP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.

SPSIP Block:

The Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of the scapula at the level of the second and third ribs on the surgical side.

Anatomical landmarks, including the trapezius, rhomboid major muscle (RMM), serratus posterior superior muscle (SPSM), and the second and third ribs will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted into the fascial plane between the SPSM and the third rip. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 30 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered. The block performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.

ESP :

The Erector Spinae Plane Block (RIB) will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processs level of the fifth thoracic vertebrae on the surgical side.

Anatomical landmarks, including the trapezius muscle, rhomboid major muscle (RMM), erector spinal muscle and transverse processes of the fifth thoracic vertebrae will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted into the fascial plane between the erector spinal muscle and fifth thoracic vertebrae. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 30 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered.

The block performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.

General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).

Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.

Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 0.15 mg/kg of intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU).

Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.

Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively. All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours. Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.

Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.

Patient and Surgeon Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.

Nausea and Vomiting

Nausea and vomiting will be scored using a 4-point scale:

0 = none

  • mild
  • moderate
  • severe

Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, or infection) will be recorded.

Being tested
Erector Spinae Plane Block (ESP), Serratus Posterior Superior Intercostal Plane (SPSIP)
Keywords
serratus posterior superior intercostal plane block, spsıp block, erector spine plane block, esp, rib fixation, regioanl anethesia
Medical subject headings
Rib Fractures, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane Block (ESP)Procedure or surgery

    Patients in this group will receive an ultrasound-guided Erector Spinae Plane Block (ESP) with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the erector spinae muscle and the fifth vertebral transverse processes, 30 minutes before surgery.

  • Serratus Posterior Superior Intercostal Plane (SPSIP)Procedure or surgery

    Patients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.

Study groups in NCT07553208
Study groupRoleWhat they receive
Serratus Posterior Superior Intercostal Plane Block (SPSIP)Active comparatorSerratus Posterior Superior Intercostal Plane
Receives: Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP)
Erector Spinae Plane Block (ESP)Active comparatorErector Spinae Plane Block
Receives: Procedure: Erector Spinae Plane Block (ESP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain intensity assessed using the Visual Analog Scale (VAS)

    Postoperative pain intensity (VAS score) Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.

    Measured: 0, 1, 4, 8, 12, and 24 hours after surgery

Secondary outcomes (7)
  1. Total opioid consumption via patient-controlled analgesia (PCA)

    Measured: Within the first 24 hours postoperatively

  2. Requirement for rescue analgesia

    Measured: Within the first 24 hours postoperatively

  3. Block performance time

    Measured: During the block procedure (intraoperative period)

  4. Block-related and systemic side effects

    Measured: Within the first 24 hours postoperatively

  5. Patient and Surgeon satisfaction assessed using a Likert scale

    Patient and surgeon satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction. Assessment will be performed at 24 hours postoperatively.

    Measured: At 24 hours postoperatively

  6. Quality of recovery assessed using the QoR-15 questionnaire

    Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery. Assessment will be performed at 24 hours postoperatively.

    Measured: At 24 hours postoperatively

  7. İncedence of postoperative nausea and vomiting(PONV)

    Measured: At 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07553208
Sponsor's protocol ID
esp-spsıp-Rib
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block (ESP) and Serratus Posterior Superior Intercostal Plane (SPSIP) in people with Rib Fracture and Postoperative Pain, run by Antalya City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mustafa KILIN, Consultant Anesthesiologist (+905464569218, mustafa.kilin90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain intensity assessed using the Visual Analog Scale (VAS) (time frame: 0, 1, 4, 8, 12, and 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in